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ISO 13485 Transferring a product from manufacturing facility 1 to manufacturing facility 2

#1
ISO 13485 Transferring a product from manufacturing facility 1 to manufacturing facility 2.

Should a transfer be treated as a new product? Should product engineering be involved.
Our company is working toward ISO 13485 certification and want to comply with 13485.
 

Pjservan

Involved In Discussions
#2
I will say that at the very least you need to confirm that at the new site the following is done: IQ- Installation Qualification, OQ- Operational Qualification and PQ- Performance Qualification. Furthermore for any type of transfer it is recommendable that you also look at customer requirements (usually as Change Control requirements).

All this with the assumption of course, that policies and procedures are the same or equivalent from one site to the other.
 
#3
ISO 13485 Transferring a product from manufacturing facility 1 to manufacturing facility 2.
Should a transfer be treated as a new product? Should product engineering be involved.
.
to flip the question., do you intend to maintain two sites independently!? vs would you treat the site-2 as an alternate site?
( i think scope is now driven by commercials and tactically keeping them independent of each site wrt customers, regulatory inspections etc)

essentially calibrate ENTIRE design controls for site-2; with appropriate assessment and revisiting from design-FMEA onwards to design transfer, design verification etc., ( depending upon the similarities and differences at both facilities) also need to have an Quality agreement if an where the 'design' is revisited at either site to ensure the updates/changes/improvements are reflected at both sites.

for making them independent, there might be additional activities of cloning the design controls + knowledge transfer to respective design teams to make them independent.

note :- i look forward for the device-gurus to comment; I am quite new and few products old in this domain.
 

moounir

Involved In Discussions
#4
Oh my god Brann828,

I am dealing with that question everyday at work and I understand that you struggle. We created a procedure to transfer products from site 1 to site 2 and this is like a checklist. (It's an internal document so cannot share that sorry)
We defined what we think is important for each department with our procedure requirements, test requirements,...

Example:
- Obsolete documents on site 1 and recreate them on the other site
- Confirm if there is a need of validation or verification
- Create the new router on the MRP
- Transfer the Raw material to site 2 and cancel it on site 1

And this is divided on phases (Planning, Implementation, Check and confirmation)

To be clear, this is a great tool to show on an audit. The auditor sees that we really take control of the transfer and this is a WIN.

The issue is that this is a huge work and regarding your question if this is like a New Product Introduction, I would say "Half-Yes"

Because on a new product introduction you have to define all the specification of a product, and test with prototypes and....
But here you already have all that. Unless you change the performance of the product at the same time.

So this is not a full New Product Introduction but it looks like that when you will present that to the team. My team is always complaining that our checklist is 100 lines and this is an important work. But in reality 40% of the list is not applicable. And it's why a planning phase is critical to clean all the things that are not needed. You still need to provide a rational why this is not needed but it's nothing in comparison to do the action.

But without this system, each of our site would perform and transfer in different manner and maybe forget some actions. This could lead to Non-conformities or recall so be careful.

So I hope this answered your question and Good luck.
 
#5
Hi All,
I am Quality Manager of company, that manufactures parts for medical industry. We are authorized to ISO-13485.
Soon our company will transfer to new site .
I need to approve company's activities in the new site.
I have some questions regarding the infrastructure approval in the new site:
- How / in what way should I to approve the new site infrastructure ?
- What the infrastructure approval include?
- Need I make laboratory analysis for drinking water (if "yes" - what parameters of drinking water should be analyzed) ? May be this not required but recommended ?
Can help me a lot, if you will give me recommendations or advice regarding the subject.

Thanks,
Molla
 

moounir

Involved In Discussions
#6
Hi Molla,

The question is not really easy to answer but I'll try.

On the ISO 13485, the infrastructure is to define "what you need to get a good product and good environment for your employees".
So this really depends on your structure and which product you have.

Let's take some examples.
  • Your products are sold sterile, so you need to have a clean room. You need then to have procedures in place to validate your clean room so it can provide the right environment for your product. You should have procedures to maintain the environment in the Clean Room.
  • So this is one example. But if you are final cleaning your products, you need also to have a monitoring of your water system to see if it is compliant to the specification of your products.
  • If you have a place to store your products and that your products are temperature sensitive, then you need to have some sensors to alert when the temperature is not on the range.

All this to say that it depends on the specification of your products.

The other part is about the specification so your employees are also in a good environment of working. For example, safe environment without chemical vapors, or no dust that can be damaging the lungs...

You see that this topic is really critical.

So what I advice is to follow a Risk Analysis process defining the specification of the products and safety of the employees. And wherever you find a risk you need to identify a way to mitigate that risk. This is the FMEA process which means Failure Mode and Effect Analysis.

This is not an exercise you can do alone so I suggest you do that with employees that know about the infrastructure of the building and the equipment.

I hope this helps you to start but this is really something that works on a case by case. So cannot provide a strategy for something that is really custom-made for you.

Wish you the best.
 

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